FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorServices Institute of Medical Sciences, Pakistan

About this trial

Chronic rhinosinusitis with nasal polyps is a condition that causes long-lasting inflammation and swelling in the nose and sinuses and may lead to nasal blockage, nasal discharge, facial pressure, and reduced sense of smell. Functional Endoscopic Sinus Surgery (FESS) is a surgical treatment used when medical treatment has not adequately controlled the condition.

Bleeding during FESS can make it difficult for the surgeon to see and operate safely. This randomized controlled trial will compare FESS performed with and without preoperative intranasal desmopressin in patients with chronic rhinosinusitis with nasal polyps. Patients will be randomly assigned to one of two groups. The intervention group will receive 20 micrograms of intranasal desmopressin 30-60 minutes before surgery, while the control group will undergo FESS without preoperative desmopressin.

The study will assess intraoperative blood loss, quality of the surgical field, operative time, surgeon satisfaction, and perioperative complications. The study will include patients undergoing elective FESS at the Department of Otorhinolaryngology, Services Hospital, Lahore.

The purpose of this study is to determine whether preoperative intranasal desmopressin can reduce bleeding and improve the surgical field during FESS. The findings may provide local evidence to help inform perioperative management of patients undergoing FESS for chronic rhinosinusitis with nasal polyps.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-60 years.

Diagnosed cases of chronic rhinosinusitis with bilateral nasal polyps.

Patients planned for elective Functional Endoscopic Sinus Surgery (FESS).

Patients with ASA physical status I or II.

Disqualifiers

Known bleeding disorders.

Fungal rhinosinusitis with polyps.

Use of anticoagulant or antiplatelet drugs.

Hyponatremia or history of hyponatremia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray

    Drug

    Intranasal desmopressin 20 μg (10 μg in each nostril) will be administered 30-60 minutes before induction of anesthesia in participants undergoing Functional Endoscopic Sinus Surgery (FESS).

  • Functional Endoscopic Sinus Surgery

    Procedure/Surgery

    Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery

Total intraoperative blood loss during FESS, measured in milliliters (mL). Blood loss will be calculated from the volume collected in the suction canister after subtracting the volume of irrigation fluid used during surgery and adding the estimated blood volume absorbed by blood-soaked nasal patties and surgical packs.

Time frame
During surgery (intraoperative period)

Secondary outcomes

1

Quality of Surgical Field During FESS

Quality of the surgical field will be assessed using the Boezaart Surgical Field Grading Scale, ranging from Grade 0 (no bleeding) to Grade 5 (severe bleeding requiring constant suctioning and preventing surgical dissection).

Time frame
During surgery (intraoperative period)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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